CD HORIZON® Spinal System 8590855Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00721902365263), received between Nov 15, 2016 and Feb 18, 2019 — classified as 1 injury, 178 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (163 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ADOLESCENT IDIOPATHI SCOLIOSIS AND UNDERWENT AN UNSPECIFIED SURGERY AT T2-L2 ON (B)(6) 2004. POST-OP, ON AN UNKNOWN DATE, THE IMPLANTED SET SCREW WAS FOUND NOT TO BE BROKEN OFF. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 IN WHICH THE SET SCREW WAS COMPLETELY EXPLANTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346750 ↗
• MalfunctionNov 29, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4/5 SEGMENTAL DISC HERNIATION, SPINAL STENOSIS AND UNDERWENT LUMBAR DECOMPRESSION AND BONE GRAFT FUSION. DURING THE SURGERY, THE SCREW SLIPPED DURING THE SCREW INSERTION PROCESS. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117952 ↗
• MalfunctionNov 29, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4/5 SEGMENTAL DISC HERNIATION, SPINAL STENOSIS AND UNDERWENT LUMBAR DECOMPRESSION AND BONE GRAFT FUSION. DURING THE SURGERY, THE SCREW SLIPPED DURING THE SCREW INSERTION PROCESS. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117948 ↗
• MalfunctionNov 29, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L4/5 SEGMENTAL DISC HERNIATION, SPINAL STENOSIS AND UNDERWENT LUMBAR DECOMPRESSION AND BONE GRAFT FUSION. DURING THE SURGERY, THE SCREW SLIPPED DURING THE SCREW INSERTION PROCESS. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117937 ↗
• MalfunctionNov 26, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL FRACTURE AND UNDERWENT LUMBAR INTERNAL FIXATION SURGERY. DURING SURGERY, THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT. THE PATIENT HAS ACHIEVED SOLID FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101029 ↗
• MalfunctionNov 26, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL FRACTURE AND UNDERWENT LUMBAR INTERNAL FIXATION SURGERY. DURING SURGERY, THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT. THE PATIENT HAS ACHIEVED SOLID FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101022 ↗
• MalfunctionNov 26, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL FRACTURE AND UNDERWENT LUMBAR INTERNAL FIXATION SURGERY. DURING SURGERY, THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT. THE PATIENT HAS ACHIEVED SOLID FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101014 ↗
• MalfunctionNov 26, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL FRACTURE AND UNDERWENT LUMBAR INTERNAL FIXATION SURGERY. DURING SURGERY, THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT. THE PATIENT HAS ACHIEVED SOLID FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100989 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPINAL STENOSIS AND UNDERWENT LUMBAR DECOMPRESSION AND INTERNAL FIXATION SURGERY. DURING SURGERY, THE SET SCREW WAS BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN SET SCREW REMAINED IN THE PATIENT. THE PATIENT HAS ACHIEVED SOLID FUSION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100922 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPINAL STENOSIS AND UNDERWENT LUMBAR DECOMPRESSION AND INTERNAL FIXATION SURGERY. DURING SURGERY, THE SET SCREW WAS BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN SET SCREW REMAINED IN THE PATIENT. THE PATIENT HAS ACHIEVED SOLID FUSION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100905 ↗
• MalfunctionNov 26, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED DURING IMPLANTATION. THIS SLIPPED SET SCREW WAS THEN COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100895 ↗
• MalfunctionNov 26, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED DURING IMPLANTATION. THIS SLIPPED SET SCREW WAS THEN COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100884 ↗
• MalfunctionNov 26, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED DURING IMPLANTATION. THIS SLIPPED SET SCREW WAS THEN COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100880 ↗
• MalfunctionNov 26, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED DURING IMPLANTATION. THIS SLIPPED SET SCREW WAS THEN COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100864 ↗
• MalfunctionNov 26, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED DURING IMPLANTATION. THIS SLIPPED SET SCREW WAS THEN COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100844 ↗
• MalfunctionNov 20, 2018Failure to Align; Failure to Align

  PROCEDURE: LUMBAR DECOMPRESSION AND BONE GRAFT FUSION IT WAS REPORTED THAT INTRA-OP, SCREW SLIPPED DURING SCREW IMPLANTATION IN THE SURGERY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8088305 ↗
• MalfunctionNov 20, 2018Failure to Align; Failure to Align

  PROCEDURE: LUMBAR DECOMPRESSION AND BONE GRAFT FUSION IT WAS REPORTED THAT INTRA-OP, SCREW SLIPPED DURING SCREW IMPLANTATION IN THE SURGERY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8088298 ↗
• MalfunctionSep 6, 2018Device Slipped; Device Slipped

  IT WAS REPORTED INTRA-OPERATIVELY THE SCREW WAS SLIPPED DURING SURGERY. THE DEVICE COME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7849825 ↗
• MalfunctionAug 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833061 ↗
• MalfunctionAug 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833051 ↗
• MalfunctionAug 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833050 ↗
• MalfunctionAug 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833019 ↗
• MalfunctionAug 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833003 ↗
• MalfunctionAug 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832987 ↗
• MalfunctionJul 12, 2018Device Slipped; Failure to Align; Failure to Align

  TYPE OF PROCEDURE OR TECHNIQUE USED: REFURBISHMENT IT WAS REPORTED THAT INTRA-OP, SET SCREW WAS SLIPPED DURING THE OPERATION . THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7684172 ↗